
Initiative at Dartmouth
CIRRICULUM
WEEK 2: REGULATORY 101
DAY 1
Arrive in the DC Area (late afternoon)
Group Dinner (early evening)
DAY 2
(Day at the FDA)
Meet and Greet, Introductions
Bram Zuckerman, MD, Office Director
Office of Health Technology 2, Cardiovascular Devices
Andrew Farb, MD, Chief Medical Officer
Office of Product Evaluation and Quality Cardiovascular Devices
FDA Device Policy
Historical Perspective
Regulatory Pathways (overview)
510K, De Novo, PMA
Preclinical Considerations
Animal Studies & Engineering
Clinical Studies
Clinical Trial Design
Evidence Evaluation
Statistical Concerns
Post-Market Considerations
Daniel Canos, PhD, Office Director
Office of Clinical Evidence and Analysis
Office of Product Evaluation & Quality
Lunch Roundtable
Reviewers, Statisticians & Engineers
Case Study
Emily Zeitler, MD, MHS, Co-Director 3D Initiative
Associate Professor of Medicine
Geisel School of Medicine at Dartmouth
Aaron Kaplan, MD, FACC, Co-Director 3D Initiative
Professor of Medicine
Geisel School of Medicine at Dartmouth
Observation of FDA Meetings
Group Dinner
DAY 3
(1/2 Day at CMS)
Meet and Greet, Introductions
Steve Farmer, MD, FACC, FASE,
Chief Strategy Officer for Coverage, CMS
CMS Authority and Bene Categories
Historical Perspective
Local vs National Coverage
Coverage with Evidence Development
TCET & Other Emerging Policies
Steve Farmer, MD, FACC, FASE
Chief Strategy Officer for Coverage, CMS
Clinical Studies
Clinical Trial Design
Evidence Evaluation
Statistical Concerns
Post-Market Considerations
Daniel Canos, PhD, Office Director
Office of Clinical Evidence and Analysis
Office of Product Evaluation & Quality
Roundtable
Reviewers, Statisticians & Engineers
Case Study
Emily Zeitler, MD, MHS, Co-Director 3D Initiative
Associate Professor of Medicine,
Geisel School of Medicine at Dartmouth
Aaron Kaplan, MD, FACC, Co-Director 3D Initiative
Professor of Medicine
Geisel School of Medicine at Dartmouth
(1/2 Day)
Consulting and Law Firms
Role of the Consulting Firm
Case Study
Group Dinner
DAY 4
Working Breakfast
Debrief
Homework
Planning and Goal Setting
Depart